LABORATORY SHARPS BARREL

Needle, Hypodermic, Single Lumen

BIOSYSTEMS

The following data is part of a premarket notification filed by Biosystems with the FDA for Laboratory Sharps Barrel.

Pre-market Notification Details

Device IDK950899
510k NumberK950899
Device Name:LABORATORY SHARPS BARREL
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale,  NY  11735
ContactJane E Rubinstein
CorrespondentJane E Rubinstein
BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale,  NY  11735
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-27
Decision Date1995-06-29

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